Johnson & Johnson
Shift: Full time
At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Automation Engineering Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Staff Automation Engineer to be based in Raritan, NJ. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment. The Staff Automation Engineer will engage in collaboration with multi-functional teams to implement solutions across automation platforms deployed in Raritan. Automation is a dedicated team of enthusiastic and skilled Automation professionals with various technical expertise, responsible for the (support of) implementation, validation, qualification and maintenance of the ISA-95 level 0 to level 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility. Automation team leads a service contractor group for 24/7 support and base business administration. This role will supervise the handled service team and also run automation project such as system upgrades or process improvements. Key responsibilities: Lead and execute technical development, qualification, planning, and lifecycle activities for process automation systems. Configure interfaces and ensure system compliance to local and global standards. Drive operational technology change, serving as the business SME and product owner for process automation, PIMS OSI-PI, Rockwell PLC, DeltaV DCS, and Siemens Desigo EMS. Be the single point of contact for ISA-95/88 L0-L2 automation systems deployed at the Raritan site. Define, monitor and report-out on system performance and business metrics. Ensure all aspects user requirement specifications and all applicable objectives are met to maintain the automation platforms (e.g. backup, disaster recovery, user administration etc.). Author and execute validation test protocols within the electronic document validation system (Kneat) per GxP. Coordinate periodic system reviews for the deployed automation. Hold and support change controls, non-conformances, and corrective and preventive actions to ensure the quality commitments are met relative to automation. Use industry experience to identify continuous improvement opportunities. Lead and steer automation improvement projects and assessments for new technology introduction. Be responsible for the oversight and effective delegation of automation development activities to external managed service providers and internal partners, as necessary. Support the OT cybersecurity workstream for the site, as necessary. Support the Raritan site readiness for FDA and health authority audits, as necessary. Establish effective relationships with Operations, Manufacturing Science and Technology, Quality, IT, Facilities, and Global teams within both Johnson Johnson and Legend Biotech. Qualifications: Education: A minimum of a Bachelor’s degree is required. A Master’s degree in Systems Engineering, Mechatronic, Computer Science, or a related field; advanced degrees (e.g., MBA) is preferred. Experience and Skills: Required: A minimum 7-8 years of relevant professional experience within a regulated pharmaceutical or biotechnology manufacturing environment is required. In-depth technical knowledge of operational technology; ISA-95/88 L0-L2 systems, including